Status:
COMPLETED
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Head and neck cancer (HNC) survivors with body image-related distress (BID) will be randomized to 5-weeks of tablet-based BRIGHT or tablet-based active control (AC; electronic information about HNC re...
Detailed Description
Following screening and informed consent, eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants (n=44) will then be...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age \> 18 years at the time of screening
- History of pathologically confirmed invasive squamous cell carcinoma (or histologic variant) of the upper aerodigestive tract (oral cavity, pharynx, larynx, nose/paranasal sinuses), carcinoma of a major or minor salivary gland, or cutaneous malignancy of the face or neck
- History of curative intent surgery with or without adjuvant therapy, with or without reconstruction
- American Joint Committee on Cancer (AJCC) 8th Edition pathologic stage grouping I-IV
- Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)
- No planned significant HNC ablative or reconstructive surgery (defined by a postoperative inpatient stay of at least three days) during the study intervention or follow-up period as determined by the HNC oncologic surgeon at the time of study accrual
- Willingness to be randomized to either BRIGHT or AC
- Body Image Scale (BIS) score \>/= 10
- Exclusion Criteria:
- Inability to speak or write English
- Pre-existing, ongoing CBT services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial.
- Initiation or adjustment (\< 3 months of baseline) of psychotropic medication.
- Severe psychiatric comorbidity (e.g. suicidal ideation, psychosis)
Exclusion
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03831100
Start Date
July 13 2020
End Date
April 20 2022
Last Update
August 9 2023
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425